Last reviewed · How we verify
Austedo (DEUTETRABENAZINE)
Austedo works by binding to the synaptic vesicular amine transporter, reducing the release of dopamine and other neurotransmitters.
Deutetrabazine (Austedo), marketed by Teva, is a leading treatment for chorea associated with Huntington’s disease, with a key composition patent expiring in 2028. Its mechanism of action, which reduces the release of dopamine and other neurotransmitters by binding to the synaptic vesicular amine transporter, distinguishes it from other treatments in its class. The primary risk to Austedo's market position is the presence of off-patent tetrabenazine, a same-class competitor with 11 generics available, potentially eroding market share.
At a glance
| Generic name | DEUTETRABENAZINE |
|---|---|
| Sponsor | Teva |
| Target | Synaptic vesicular amine transporter |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 1100 |
Mechanism of action
The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia and chorea in patients with Huntingtons disease is unknown but is believed to be related to its effect as reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (-dihydrotetrabenazine [HTBZ] and -HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
Approved indications
- Chorea associated with Huntington’s disease
- Tardive dyskinesia
Boxed warnings
- WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. Increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease ( 5.1 ) Balance risks of depression and suicidality with the clinical need for treatment of chorea when considering the use of AUSTEDO XR or AUSTEDO ( 5.1 ) Monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior ( 5.1 ) Inform patients, caregivers, and families of the risk of depression and suicidality and instruct to report behaviors of concern promptly to the treating physician ( 5.1 ) Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 ) AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression ( 4 , 5.1 )
Common side effects
- Somnolence
- Diarrhea
- Dry mouth
- Fatigue
- Nasopharyngitis
- Insomnia
- Urinary tract infection
- Anxiety
- Constipation
- Contusion
- Dizziness
- Agitation
Key clinical trials
- Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities (PHASE4)
- Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease (PHASE2,PHASE3)
- A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (PHASE4)
- Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD (PHASE1)
- An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia (PHASE1,PHASE2)
- A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy (PHASE3)
- A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (PHASE3)
- Reducing Involuntary Movements in Participants With Tardive Dyskinesia (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Austedo CI brief — competitive landscape report
- Austedo updates RSS · CI watch RSS
- Teva portfolio CI